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OpenTrials
Completed

NCT Number: NCT00988390

Mothers Living With HIV and Their Adolescent Children

* Context: Mothers living with HIV (MLH) and their children face predictable challenges: maintaining physical and mental health, parenting while ill, and addressing HIV-related stressors. * Objective: To evaluate the efficacy of a family-based intervention over time; to contrast the life adjustments of HIV-affected families and their non-HIV-affected neighbors in the current treatment era. * Design: Randomized controlled trial of MLH and a longitudinal comparison of MLH to a neighborhood cohort using random effect regression. * Participants and Intervention: MLH (n = 339) and their school-age children (n = 259) were randomly assigned to receive 1) an intervention of 16 sessions in a cognitive-behavioral, small-group format; or 2) control. MLH and their children were compared to non-HIV-affected families recruited at shopping markets. Participant retention was high: 84% at 6 months, 83% at 12 months, and 78% at 18 months. * Main Outcome Measures: Family functioning and conflict, mental and physical health, sexual behavior, and substance use.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Intervention/Control, mother living with HIV:

  • Mother or primary female caregiver
  • Enrolled in HIV-related clinical cares
  • At least one child between the age of 6 and 20 years

Inclusion criteria

for neighborhood control, non-HIV-affected mother:

  • Mother or primary female caregiver
  • not HIV-positive
  • At least one child between the age of 6 and 20 years

Exclusion criteria

(Intervention/Control/Neighborhood):

  • Mother less than 18 years old
  • Unable or willing to give informed consent
  • Psychosis or neurological damage as judged by the investigator in consultation with clinical supervisor

Treatment and study plan

Cognitive-behavioral, small-group format sessions

Behavioral

The intervention was delivered in either English- or Spanish-speaking groups of 5 to 8 mothers living with HIV twice weekly for 1.5 to 2 hours each over eight weeks (n = 16 sessions).

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: TALK LA

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 2, 2009
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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